Nge-13 ka-Okthobha, bangaphezulu kwe-180 abantu abavela kuphando lwesitofu sokugonya kunye neshishini lophuhliso badibana kwiHolo yaseChengdu yaseShanghai Hope Hotel.Ootitshala abalishumi abaphuma kuphando kunye nophuhliso lweshishini lokulwa neziyobisi kunye namaziko ophando lwezenzululwazi nabo bazise ukwabelana okumangalisayo.
Ukuqala kwingcinga kunye nokusetyenziswa kwezilwa-buhlungu, uGqr. Zhang Aihua uxoxe ngokuhlelwa kunye nokubizwa kwamachiza e-antibody.Ethatha i-CD47 njengomzekelo, uGqr. Zhang ucacise ngendlela yokusebenza kunye nokusetyenziswa kwezonyango kwamachiza e-antibody.Okwangoku, uphando kunye nophuhliso lwee-antibodies ze-monoclonal zitshisa kakhulu.Kwinkqubo yophuhliso, kufuneka sahlule umahluko phakathi kophuhliso lwe-antibodies entsha kunye nokulawulwa komgangatho we-Biosimilar.Ekuphuhlisweni kweziyobisi ezintsha, uphando olusemgangathweni olufanelekileyo kufuneka lwenziwe ngokuhambelana nengcamango yophuhliso lomgangatho ovela kuyilo (QbD) kunye nomgaqo wokhuseleko, ukusebenza, kunye nomgangatho olawulekayo.
UDkt Wang Gang, usosayensi oyintloko, wayejongene nokuthotyelwa kunye nokuhlolwa kwi-CFDA Drug Review Centre (CDE).Wazisa isakhelo soLawulo lweZiyobisi zikaRhulumente zaseTshayina, yinkqubo yomthetho yamanqanaba amathathu emithetho, imimiselo, kunye nezikhokelo zobugcisa zoLawulo lweZiyobisi zikaRhulumente.Uye wazisa neenkqubo zobhaliso kunye nokuvunywa kweSicelo seLayisensi yeeMveliso zeBiological yaseTshayina (i-BLA) kunye neSicelo esitsha seziyobisi (NDA).Uqinisekisile ukuba uhlaziyo lolawulo, umthetho, kunye neenkqubo zokuvunywa kweziyobisi zoLawulo lweZiyobisi zikaRhulumente ziya kukhuthaza kakhulu ukuphuhliswa kwamachiza amatsha e-China, kwaye uthelekise inkqubo yokuhlola ulawulo lwe-Food and Drug Administration of Europe and United States.Ekugqibeleni, wabonisa iimbono zakhe malunga nohlaziyo lwexesha elizayo lwenkqubo yolawulo lwamayeza eTshayina.UGqr Wang uye wasikhokelela ukuba sihlolisise umgaqo othile wezilungiso kuMthetho woLawulo lweZiyobisi weRiphabhlikhi yaBantu baseTshayina kunye neMimiselo yoBhaliso lweDrugs kunye noLawulo, kunye nefuthe labo elifikelela kude kwishishini leR & D lamachiza kwiminyaka yamuva.
I-Counttar Rigel eyaphuhliswa ngokuzimeleyo yi-ALIT Life Sciences ifanelekile kwisiganeko sobugcisa kunye negolide njengale.I-Countstar Altair yenzelwe ngokukodwa eli shishini.Ulawulo lwayo lwedatha kunye nokusebenza kokulawula kuhambelana ngokupheleleyo ne-FDA 21 CFR Part11.Iyakwazi kwakhona ukubonelela ngeenkonzo zokuqinisekisa ze-3Q kwiintlobo ngeentlobo zeegranule zokuqinisekisa.Isombulula ngokupheleleyo amaxhala abathengi bamashishini malunga nolawulo lomgangatho.
Kwindawo yenkomfa, uninzi lweengcali zolu shishino zeza ukuza kunxibelelana kwaye zixoxe, kwaye wonke umntu uye waqinisekisa ngamxhelo mnye ukusebenza nokuthotyelwa kukaRigel.I-Countstar iya kuqhubeka nokugcina isimo sengqondo esingqongqo kunye nesazela sesayensi, siphucula rhoqo, kwaye sincede umzi-mveliso we-antibody ube nophuhliso olungcono.
I-Countstar Altair ibonelela ngenkonzo yovavanyo lweprototype, kwaye yamkele wonke umntu ukuba afake isicelo!
